DEVICE 1960100 SINUS WASH SYSTEM

DEVICE 1960100 SINUS WASH SYSTEM
HYDROCLEANSE™ - 1960100

A collection of sterile items intended to dispense a solution to penetrate, clear, and clean the nasal passages and sinus cavity for the relief of nasal and sinus symptoms (e.g., nasal congestion, sinus pressure, secretions, nasopharyngeal discharge, encrustations, nasal dryness) and/or before, during and/or after ENT surgery. It typically includes an irrigation bottle/canister/syringe which can include a pumping mechanism, actuator tips and adaptors for various solution-delivery applications and connector tubing. This device is intended to be used by a professional in a clinical setting. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KAR

Device Name: Irrigator, Sinus

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: EN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 874.4420

Third Party Flag: N

Medical Specialty: EN

Device Id: 00643169864429

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A